Orientation for New Clinical Research Personnel

This four-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The objectives are to introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research.

When Sep 04, 2013 01:00 PM to
Sep 25, 2013 03:00 PM
Where Brinkhous-Bullitt Room 219
Contact Name
Contact Phone 919-966-6844
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Pre-requisites to attend these trainings are completion of the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules available online at: https://www.citiprogram.org/Default.asp

The orientation is divided into 4 weekly modules, held on Wednesdays from 1:00 - 3:00 PM. Research personnel are encouraged to attend all 4 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered during each module include:

September 4, 2013: Week 1 module – Overview of Orientation and IRB Process
• Introduction and overview of clinical research orientation
• NCRP and educational programs for research personnel
• IRB overview

September 11, 2013: Week 2 module – Study Implementation and Good Clinical Practices
• Study implementation and roles of research personnel
• Good Clinical Practices and study documentation
• Informed consent process

September 18, 2013: Week 3 module –Contracting and Clinical Trial Administrative Elements
• Conflict of interest
• Contracts and clinical trial agreements
• ClinicalTrials.gov and ICMJE requirements
• Hospital device management policy& Investigational Drug Service

September 25, 2013: Week 4 module – Clinical Trial Management, Hospital Accounting and Budgeting
• Clinical Research Management System (CRMS) overview
• Hospital accounting and routing of charges
• Budgeting for clinical research, accounting of research funds
• Medicare coverage analysis

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